A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Outpatient, Parallel-Group Study to Assess the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
UCB Biopharma SRL
Summary
The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must be ≥12 years of age at the Baseline/Randomization Visit * Participant must have a study caregiver ≥18 years of age at the Screening Visit; the study caregiver(s) must be a relative, partner, friend, or legally authorized representative (LAR) of the participant, or a person who provides daily care to the participant and has a significant personal relationship with the participant; the study caregiver(s) must be able to recognize and observe the participant's seizures * Participants with an established diagnosis of focal or generalized epilepsy or combined…
Interventions
- DrugStaccato alprazolam
Route of administration: Inhalation Participants will receive one dose of Staccato alprazolam during the Treatment Period.
- OtherPlacebo
Route of administration: Inhalation Participants will receive one dose of placebo during the Treatment Period.
Locations (183)
- Ep0162 50506Phoenix, Arizona
- Ep0162 50720Scottsdale, Arizona
- Ep0162 50494Little Rock, Arkansas
- Ep0162 50118Downey, California
- Ep0162 50416La Jolla, California
- Ep0162 50702Long Beach, California